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Description de l'emploi
The Pharmacovigilance Manager works under the hierarchical supervision of the Head of Pharmacovigilance.
Main responsibilities / Major Activities:
Ensures that Serious Adverse Events are handled according to what is described in the Pharmacovigilance latest SOP
- By preparing the SAE-form/e-SAE forms and guidelines and providing them to the Data Manager of the study.
- By checking that in Pharmacovigilance Department all documents are available and that all procedures are clear at the study opening and after any amendment.
- By performing quality checks on incoming safety information.
- By requesting supplementary information whenever necessary and forwarding queries.
- By asking advice and guidance to a medical doctor when information contained in a SAE report is unclear.
- By managing the new report in the Pharmacovigilance Database
- By processing reports electronically once they are in electronic systems
- By making sure that all information is updated and distributed appropriately within the specified timelines.
- By tracking all requests based upon to regulatory deadlines.
- By being responsible of safety reporting to competent authorities, ethics committees and investigators.
- By informing the Pharmacovigilance Administrator when a case or Development Safety Update Report is reportable based upon latest reporting requirements document.
- By reporting SAEs, line listings and other safety information to appropriate persons and entities.
- By reviewing SAE-summaries, cover templates and other documents prepared by the Pharmacovigilance /staff.
- By attending project based team meetings, phone conferences and any other safety related meetings.
- By giving support to Data Manager during the SAE reconciliation.
- By helping in the production of the Development Safety Update Report by preparing the non-medical parts of the Development Safety Report and by providing information for the medical author.
- Contributes to the protocol development: attends phone conferences and meetings (team and external partners), completes the Pharmacovigilance section of the protocol. Writes and reviews the Pharmacovigilance content of the group specific appendix when appropriate.
- Reviews the safety agreement and contract.
- During the study contributes to requests by other teams (medical, regulatory, clinical operations, data management, contracts and project management).
- Gives presentations of Pharmacovigilance Department to new staff members and to non-EORTC staff members.
- Gives pharmacovigilance trainings to company's staff members and to non-company staff members.
- Performs and gives contribution to non-study specific pharmacovigilance tasks.
- Master’s Degree in Life Sciences (medical/biomedical sciences, pharmaceutical sciences,…)
- 2-5 years SAE processing/clinical safety/pharmacovigilance experience
- Knowledge of clinical/pharmacovigilance regulations
- Knowledge of safety database(s) and/or EudraVigilance submissions
- Good communication skills: fluent English (spoken and written)
- Ability to work in a structured way and independent way
- Must be able to prioritize/motivated to meet the reporting deadlines
- Must be a team player, strong diplomatic skills